Topic Highlight
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 14, 2016; 22(26): 5909-5916
Published online Jul 14, 2016. doi: 10.3748/wjg.v22.i26.5909
Is endoscopic papillary balloon dilatation really a risk factor for post-ERCP pancreatitis?
Toshio Fujisawa, Koichi Kagawa, Kantaro Hisatomi, Kensuke Kubota, Atsushi Nakajima, Nobuyuki Matsuhashi
Toshio Fujisawa, Koichi Kagawa, Kantaro Hisatomi, Nobuyuki Matsuhashi, Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo 141-8625, Japan
Kensuke Kubota, Atsushi Nakajima, Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama 236-0027, Japan
Author contributions: Fujisawa T, Kubota K, Nakajima A and Matsuhashi N planned and designed the study; Fujisawa T, Kubota K, Hisatomi K and Kubota K performed the EPBD/EPLBD comparisons; Fujisawa T, Hisatomi K and Matsuhashi N wrote the manuscript; All authors approved the authorship.
Conflict-of-interest statement: No potential conflicts of interest. No financial support.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Toshio Fujisawa, MD, PhD, Department of Gastroenterology, NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa, Tokyo 141-8625, Japan. toshio.fujisawa@east.ntt.co.jp
Telephone: +81-3-34486111 Fax: +81-3-34486541
Received: February 13, 2016
Peer-review started: February 13, 2016
First decision: March 21, 2016
Revised: March 23, 2016
Accepted: April 7, 2016
Article in press: April 7, 2016
Published online: July 14, 2016

Abstract

Endoscopic papillary balloon dilatation (EPBD) is useful for decreasing early complications of endoscopic retrograde cholangio-pancreatography (ERCP), including bleeding, biliary infection, and perforation, but it is generally avoided in Western countries because of a relatively high reported incidence of post-ERCP pancreatitis (PEP). However, as the efficacy of endoscopic papillary large-balloon dilatation (EPLBD) becomes widely recognized, EPBD is attracting attention. Here we investigate whether EPBD is truly a risk factor for PEP, and seek safer and more effective EPBD procedures by reviewing past studies. We reviewed thirteen randomised control trials comparing EPBD and endoscopic sphincterotomy (EST) and ten studies comparing direct EPLBD and EST. Three randomized controlled trials of EPBD showed significantly higher incidence of PEP than EST, but no study of EPLBD did. Careful analysis of these studies suggested that longer and higher-pressure inflation of balloons might decrease PEP incidence. The paradoxical result that EPBD with small-calibre balloons increases PEP incidence while EPLBD does not may be due to insufficient papillary dilatation in the former. Insufficient dilatation could cause the high incidence of PEP through the use of mechanical lithotripsy and stress on the papilla at the time of stone removal. Sufficient dilation of the papilla may be useful in preventing PEP.

Key Words: Endoscopic papillary balloon dilatation, Post-endoscopic retrograde cholangio-pancreatography pancreatitis, Endoscopic papillary large-balloon dilatation, Endoscopic sphincterotomy, Randomized controlled trial

Core tip: Some recent studies suggest that Endoscopic papillary balloon dilatation (EPBD) itself does not increase post-endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis (PEP) incidence. Theoretically, endoscopic papillary large-balloon dilatation (EPLBD) can damage the papilla more than EPBD does, but even direct EPLBD without preceding sphincterotomy does not increase PEP rate. An explanation for this paradox is that procedures following EPBD, but not EPBD itself, induce PEP. Since the EPBD stress is limited around the papilla, a prophylactic pancreatic stent could protect against the damage related to EPBD. EPBD has many advantages that endoscopic sphincterotomy does not. Therefore, it is time to re-evaluate the risks and efficacy of EPBD, and to utilize it suitably instead of shelving it.



INTRODUCTION

Staritz et al[1] originally introduced endoscopic papillary balloon dilatation (EPBD) in 1983. It was developed to avoid complications of endoscopic sphincterotomy (EST) such as bleeding, perforation, and biliary infection. EPBD became popular because it was easier to perform than EST and had a possibility of preserving the function of the Oddi sphincter. However, one complication of EPBD caused anxiety: an increase in post-endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis (PEP). Many researchers studied the efficacy and safety of EPBD and found it to be feasible and acceptable, with the exception of one study. Disario et al[2] performed an international multicentre study in 2004 and reported that the incidence of severe complications in the EPBD group was significantly higher than the EST group, and that two patients in the EPBD group died due to PEP. This result frightened many endoscopists, and EPBD has since been regarded as a risky procedure. EPBD has been avoided in Western countries, although it is still popular in Asian countries. On the other hand, EPBD using a large-calibre balloon (10-20 mm in diameter, endoscopic papillary large balloon dilatation; EPLBD) was recently developed for retrieving large and/or piled biliary stones, and the efficacy and safety of EPBD were also re-evaluated[3-7].

Here, we review past studies of EPBD/EPLBD, and re-evaluate the incidence of PEP following EPBD. In addition, we discuss a safer EPBD protocol for decreasing complications.

REPORTED PROS AND CONS OF EPBD AND EST

The characteristics of EPBD are briefly summarized in Table 1. The pros and cons of EPBD have been often compared to those of EST First, EPBD is technically easier and more beginner-friendly than EST. It can be adopted even in cases in which the ampulla is in a large diverticulum or cases with limited endoscopic views.

Table 1 Pros and Cons of endoscopic papillary balloon dilatation.
ProsCons
Endoscopic papillary balloon dilatation1Beginner-friendlyMore pancreatitis?
Less bleedingLower success rate of stone removal?
Less perforation?
Less biliary infection?
Adaptive to altered anatomy
Preserved sphincter function

Second, EPBD has lower rates of bleeding. Indeed, one of the greatest aims of developing EPBD was to avoid post-procedural bleeding. A meta-analysis of 15 randomized clinical trials and 1768 participants showed that EPBD had significantly lower rates of bleeding than EST[8]. Indeed, the claim of lower incidence of bleeding after EPBD is supported by most meta-analyses[9-11]. Effects on the rates of perforation and biliary infection, however, are not consistent among the reports[9-12].

Third, EPBD has advantages in patients with surgically altered anatomy after gastrectomy or gastric bypass surgery. In patients with Billroth II anastomoses, EPBD is associated with a significantly lower rate of bleeding, but not a higher rate of pancreatitis compared to EST[13]. Only large biliary stone size and repeated ERCP procedures are suggested as risk factors for complications in Billroth II anastomosis cases[14]. In patients with Roux-en-Y anastomoses, EPBD combined with balloon-assisted enteroscopy is also useful[15].

Finally, EPBD can preserve the function of papillary sphincter even after papillary manipulation[16]. EST destroys the function of the sphincter, often permanently. The elimination of sphincter function may allow duodenobiliary reflux and lead to recurrence of biliary stones and biliary infection. Animal studies reveal that long-lasting exposure to digestive enzymes and bacteria in the bile duct induces epithelial hyperplasia and dysplasia[17,18]. In an animal study using live pigs, EPBD caused no architectural distortion or smooth muscle disruption, although EST caused transmural haemorrhage, smooth muscle disruption, and mucosal necrosis in the papillary structure[19]. In a histological study of humans, EPBD mostly preserved the papillary architecture and smooth muscle[20]. In a study using a quantitative cholescintigraphy, hilum-duodenum transit time after EST was significantly shorter than in controls, but EPBD preserved hilum-duodenum transit time[21]. Moreover, studies using manometry or MRI reveal that EPBD can preserve papillary function better than EST[16,22,23]. Some studies also examined long-term outcomes. Over several years of follow-up, fewer patients develop biliary infections and recurring biliary stones after EPBD compared to EST[24-27]. However, the effects of EPBD/EST on bile duct carcinogenesis have not been elucidated yet[28].

In contrast to the multiple advantages of EPBD over EST, disadvantages of EPBD are few. Some studies suggest that EST is superior to EPBD in terms of success rate of stone removal. EPBD has also been associated with a higher incidence of PEP than EST. In this review we will try to elucidate whether these two disadvantages of EPBD really exist.

FACTORS IN CONVENTIONAL EPBD

An EPBD procedure consists of several variable factors: balloon size, pressure of inflation, duration of balloon dilation (ballooning time), frequency of inflation, and inflation speed. There is no standard technique dictating these factors, although guidelines for EPBD have been published[29-32]. We summarized EPBD procedures used in past randomized controlled trials (RCTs), compared EST and conventional EPBD using small calibre balloons, and evaluated the methods in terms of PEP rate and therapeutic efficacy (Table 2)[2,13,22,25,33-41]. A total of 13 RCTs were included in the analysis[2,13,22,25,33-41]. Simple comparisons of PEP rate were difficult, because they varied widely among the RCTs. Therefore, we divided the studies into two groups: one group that showed significant differences in the PEP rate between EPBD and EST (significant group)[2,33,34], and another group that did not (non-significant group)[13,22,25,35-41]. There was no study that showed a higher PEP rate in EST than in EPBD. Three RCTs[2,33,34] reported that the PEP rate of EPBD was significantly higher than EST, but the remaining 10 RCTs[13,22,25,35-41] did not show a significant difference. Three RCTs[34,37,38] reported that the rate of therapeutic success in the first session was significantly lower in the EPBD group than in the EST group, and three other RCTs[22,34,36] revealed that frequency of mechanical lithotripsy (ML) use in the EPBD group was higher than that in the EST group.

Table 2 Endoscopic retrograde cholangio-pancreatography pancreatitis rates in endoscopic papillary balloon dilatation and endoscopic sphincterotomy in ramdomized control trials.
Ref.Study designYearTotal patientsSignificant difference from the control
Percentage of PEP
Balloon size (mm)Maximum pressure (atm)Ballooning time (s)Dilatation speedNote
Therapuetic successML usePEP rateEPBDEST
SignificantFujita et al[33]RCT2003282--EPBD > EST10.92.88Waist disappear153 min
Disario et al[2]RCT2004237--EPBD > EST10.30.88Maximum60NM2 deaths in EPBD
Watanabe et al[34]RCT2007180EST > EPBDEPBD > ESTEPBD > EST16.76.787120NM
Non-significantMinami et al[35]RCT199540---10.010.08NM180NMManometry
Bergman et al[36]RCT1997202-EPBD > EST-6.96.981245-601-2 min1 death in EPBD
Ochi et al[37]RCT1999110EST > EPBD--03.78860 × 3 timesNM
Arnold et al[38]RCT200160EST > EPBDNM-20.010.081060 × 2 timesNM
Yasuda et al[22]RCT200170-EPBD > EST-5.75.78660 × 2 timesNMManometry
Bergman et al[13]RCT200134---6.2081045-601-2 minBillroth II
Natsui et al[39]RCT2002140---5.74.388120NM
Vlavianos et al[40]RCT2003202---4.81.0101230NM
Tanaka et al[41]RCT200432---18.818.888120NMLong-term outcome
Seo et al[25]RCT2014132---8.17.16-10Stone size90-120GraduallyAge < 40 yr

There was no obvious difference in EPBD procedures between the significant group[2,33,34] and the non-significant group[13,22,25,35-41]; however, the maximum pressure and ballooning time in the significant group tended to be lower and shorter, respectively, than in the non-significant group. Balloon size and dilatation speed were similar between the two groups. Thus, higher pressure (> 8 atm) and longer inflation (> 60 s) might be associated with lower PEP incidence in EPBD.

EPLBD WITHOUT PRECEDING EST

In addition to EPBD analysis, we compared the same parameters between reported studies comparing EPLBD and EST (Table 3)[42-51]. EPLBD following EST was excluded, because preceding EST may affect the incidence of PEP. We sorted a total of 10 studies in descending order of the PEP rate. Seven of the 10 studies compared EST groups and EPLBD with preceding EST groups[42-46,48,51]. In all seven studies, the rates of therapeutic success, ML use, and PEP were not significantly different between the EPLBD and control groups. EPLBD without preceding EST removed large stones as easily and safely as EST. In EPLBD cases, there was no association between balloon size and PEP incidence. The dilatation speed was described as “gradual” in most studies. There were two methods to determine the maximum pressure of ballooning: one was stopping at the pressure of balloon waist disappearance, and the other was ballooning up to the size of stones. When ballooning up to the size of large stones, the waist usually disappeared before the balloon reached the target size. In the two studies[50,51] with the lowest PEP incidence, longer (> 4 min) and higher-pressure (dilation up to the size of stones) inflation methods were adopted compared to the other eight studies[42-49]. As with conventional EPBD with smaller calibre balloons, longer and higher-pressure inflation might also decrease PEP incidence in EPLBD.

Table 3 Post-endoscopic retrograde cholangio-pancreatography pancreatitis rates after endoscopic papillary large-balloon dilatation without preceding endoscopic sphincterotomy.
Ref.Study designYearTotal patientsSignificance compared to the control
Percentage of PEP
Mean balloon size (mm)Maximum pressureMean ballooning time (s)Dilatation speed
Therapuetic successML usePEP rateEPLBD aloneEST alone
Minakari et al[42]RCT2013160-NM-11.28.715.0Size of stones60NM
Kim et al[43]R2013223---10.96.815.6Waist disappear38With caution
Hwang et al[44]R2013131---6.54.315.9Size of stones60Gradually
Li et al[45]R2015109---6.34.914.2Size of stones60Gradually
Oh et al[46]RCT201283---5.07.011.8Waist disappear31Gradually
Omuta et al[47]Pros201541N/AN/AN/A4.9N/A10-20Size of stones0Gradually
Kogure et al[48]Pros201442---4.07.0114.0Waist disappear15-60Gradually
Jeong et al[49]R200938N/AN/AN/A2.6N/A15.5Waist disappear53Gradually
Chan et al[50]R2011247N/AN/AN/A0.8N/A13.2Size of stones282NM
Lin et al[51]RCT2004104---008-12Size of stones300NM

Thus, the data imply that conventional EPBD might be associated with an increased rate of PEP, but EPLBD without preceding EST is not (Tables 2 and 3). How should we interpret these paradoxical results? In the past reports, three reasons were suggested[4]. First, frequency of MLT use is decreased in EPLBD. Second, the patients who receive EPLBD are relatively older. Younger age is supposed to be a risk factor of PEP[52]. Third, EPLBD makes selective cannulation into the bile duct easier and decreases incorrect cannulation and injection into the pancreatic duct. If factors other than the balloon size are not different, EPLBD theoretically could damage the papilla more than EPBD. Therefore, it seems that papillary damage itself does not cause PEP, but rather, other procedures accompanying EPBD could cause PEP.

BALLOON SIZE, INFLATION TIME, AND INFLATION PRESSURE

Then, what is the best method of EPBD? There have been few studies evaluating the details of EPBD procedures. Concerning balloon size, Akiyama et al[53] compared efficacy and safety between 10-mm-wide and 8-mm-wide balloons. The rate of complete stone removal within a single session was higher and use of lithotripsy was lower with a 10-mm-wide balloon than with an 8-mm-wide balloon. PEP and other complication rates were similar between the two balloon sizes. Li et al[54] also studied the PEP rate for different balloon sizes and reported no difference. However, interpreting their study is difficult because of the small numbers of patients in each group (a total of 208 cases in five groups).

Liao et al[55] studied the duration of balloon dilatation. The success rate of stone removal was higher and the PEP rate was lower with 5-min dilatation than with 1-min dilatation. In a meta-analysis reviewing randomized controlled trials, long EPBD (> 1 min) decreased not only PEP risk, but also the overall rate of complications. Conversely, short EPBD (≤ 1 min) had a higher risk of PEP than EST[12]. Based on these results, ESGE guidelines for prophylaxis of post-ERCP pancreatitis recommend balloon dilatation for more than 1 min[31]. Bang et al[56] however, reported that efficacy and safety are not significantly different between 20-s and 60-s dilatations. On the other hand, Kuo et al[57] reported that papillary dilatation longer than 3 min increases the risk of recurrent biliary stones. Therefore, longer dilatation could decrease the PEP rate, but could damage the function of the papillary sphincter.

Concerning the dilatation pressure, Tsujino et al[58] compared the PEP rate in EPBD methods between one group with EPBD at 8 atm maintained for 2 min and another with the pressure at disappearance of the balloon waist maintained for 15 s. The success rate and the PEP rate were not significantly different between the two groups. There is no study on the speed of balloon dilatation, but Japanese guidelines recommend gradual dilatation just until the waist of the balloon disappears[29].

Seo et al[59] compared the PEP rate between EPBD (retrograde dilatation) and percutaneous transhepatic papillary balloon dilatation (anterograde dilatation). The PEP rate was significantly higher after retrograde dilatation compared to anterograde dilatation. The authors considered that PEP might be associated with procedures before or after balloon dilatation, including contrast medium injection into the pancreatic duct and mechanical lithotripsy, rather than balloon dilatation itself. Lastly, Tsujino et al[60] examined risk factors for PEP after EPBD and identified only contrast medium injection into the pancreas as a risk factor.

DISCUSSION

The mechanism of EPBD-related PEP is still unclear. Damage to the pancreatic duct during papillary dilatation and papillary oedema or spasm after dilatation are potentially associated with induction of PEP. If the damage by EPBD is localized to the papilla, the placement of a prophylactic pancreatic stent could prevent EPBD-related PEP[61]. Unfortunately, studies evaluating the efficacy of prophylactic pancreatic stents after EPBD have not been reported yet. However, the ESGE guidelines recommend placement of a prophylactic pancreatic stent when EPBD is performed, on the basis of this theoretical consideration[31]. In addition to prophylactic pancreatic stents, endoscopic nasobiliary drainage (ENBD) attracts attention as a possible preventive measure for PEP after EPBD. ENBD has disadvantages of discomfort and cosmetic problem, and is rarely used in Western countries, although it is often used in Asian countries[62]. Some studies show that ENBD is effective for PEP prevention after EPBD[63-65]. It is speculated that ENBD reduces PEP rate by preventing pancreatic juice obstructions caused by residual stones or papillary oedema.

As mentioned above, the success rate of stone removal is significantly lower, and PEP rate is significantly higher in conventional EPBD than in EST. However, complication rates are not different between EPLBD and EST. This might be because papillary dilatation by EPBD with small calibre balloons is often insufficient for stone removal, and sufficient dilatation can increase success rate and decrease PEP rate. Insufficient dilatation by EPBD may also increase the rate of mechanical lithotripsy use and may place stress on the papilla at the time of stone removal. Insufficient dilatation could lead to entrapment of residual stones at the papilla and could impair pancreatic drainage[66,67]. Insufficient dilatation of the papilla seems to be one of the reasons for the high PEP rate in conventional EPBD. Results showing that longer and larger dilatation is better for PEP prevention also support this insight[12,53,55]. Therefore, the papilla should be dilated to a sufficient size with enough pressure.

The maximal pressure applied in EPBD procedures may play an important role both in stone removal efficacy and safety. Among the 10 EPLBD studies in Table 3, six and four studies used the stone size[42,44,45,47,50,51] and waist disappearance[43,46,48,49] approaches, respectively. No significant differences in stone removal efficacy, ML use rate, and PEP rate were observed between the two approaches. Considering that EPBD with a 10-mm balloon achieved better efficacy and safety compared to that with an 8-mm balloon[53], there is a possibility that adequate balloon size and pressure contribute to better efficacy and safety of EPBD procedures. In the waist-disappearance approach, the papilla dilatation effect with larger balloons may be greater than that with smaller balloons.

Ethnicity may have an impact on EPBD-related PEP rate. In a meta-analysis showing a higher PEP rate in EPBD groups than in EST groups, detailed analysis indicated that EPBD increased the PEP rate in Western patients (P < 0.0001), but not in Asian patients (P = 0.08)[11]. In the study, only Western patients in the EPBD group experienced deadly pancreatitis[2]. On the other hand, prospective studies of Asian patients show that results with EPBD and EST are both acceptable, although the PEP rate tends to be higher in the EPBD group[9-12]. Sensitivity for EPBD-related PEP may have racial differences, just as the effects of drugs are different between different ethnic groups. In the future, endoscopic treatment procedures might be selected with consideration for the patient’s racial and genetic background.

CONCLUSION

At present, EPBD is generally recognized to be a risk factor of PEP. However, some studies suggested that balloon dilatation itself does not cause PEP, but procedures accompanying insufficient dilatation of the papilla can cause PEP. The mechanism of EPBD-related PEP should be further investigated. Until then, when EPBD is performed for stone removal, it seems to be better to dilate the papilla sufficiently (ballooning size > stone size, at least 8 mm with sufficient pressure for opening the waist; and ballooning time > 60 s) and to place a prophylactic pancreatic stent in order to prevent PEP.

Footnotes

P- Reviewer: Alexopoulou A, Boros M, Wang K S- Editor: Qi Y L- Editor: A E- Editor: Wang CH

References
1.  Staritz M, Ewe K, Meyer zum Büschenfelde KH. Endoscopic papillary dilation (EPD) for the treatment of common bile duct stones and papillary stenosis. Endoscopy. 1983;15 Suppl 1:197-198.  [PubMed]  [DOI]
2.  Disario JA, Freeman ML, Bjorkman DJ, Macmathuna P, Petersen BT, Jaffe PE, Morales TG, Hixson LJ, Sherman S, Lehman GA. Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones. Gastroenterology. 2004;127:1291-1299.  [PubMed]  [DOI]
3.  Lai KH, Chan HH, Tsai TJ, Cheng JS, Hsu PI. Reappraisal of endoscopic papillary balloon dilation for the management of common bile duct stones. World J Gastrointest Endosc. 2015;7:77-86.  [PubMed]  [DOI]
4.  Jang SI, Yun GW, Lee DK. Balloon dilation itself may not be a major determinant of post-endoscopic retrograde cholangiopancreatography pancreatitis. World J Gastroenterol. 2014;20:16913-16924.  [PubMed]  [DOI]
5.  Jeong SU, Moon SH, Kim MH. Endoscopic papillary balloon dilation: revival of the old technique. World J Gastroenterol. 2013;19:8258-8268.  [PubMed]  [DOI]
6.  Aiura K, Kitagawa Y. Current status of endoscopic papillary balloon dilation for the treatment of bile duct stones. J Hepatobiliary Pancreat Sci. 2011;18:339-345.  [PubMed]  [DOI]
7.  Fujisawa T, Kagawa K, Hisatomi K, Kubota K, Nakajima A, Matsuhashi N. Endoscopic papillary large-balloon dilation versus endoscopic papillary regular-balloon dilation for removal of large bile-duct stones. J Hepatobiliary Pancreat Sci. 2014;21:405-409.  [PubMed]  [DOI]
8.  Weinberg BM, Shindy W, Lo S. Endoscopic balloon sphincter dilation (sphincteroplasty) versus sphincterotomy for common bile duct stones. Cochrane Database Syst Rev. 2006;CD004890.  [PubMed]  [DOI]
9.  Baron TH, Harewood GC. Endoscopic balloon dilation of the biliary sphincter compared to endoscopic biliary sphincterotomy for removal of common bile duct stones during ERCP: a metaanalysis of randomized, controlled trials. Am J Gastroenterol. 2004;99:1455-1460.  [PubMed]  [DOI]
10.  Liu Y, Su P, Lin S, Xiao K, Chen P, An S, Zhi F, Bai Y. Endoscopic papillary balloon dilatation versus endoscopic sphincterotomy in the treatment for choledocholithiasis: a meta-analysis. J Gastroenterol Hepatol. 2012;27:464-471.  [PubMed]  [DOI]
11.  Zhao HC, He L, Zhou DC, Geng XP, Pan FM. Meta-analysis comparison of endoscopic papillary balloon dilatation and endoscopic sphincteropapillotomy. World J Gastroenterol. 2013;19:3883-3891.  [PubMed]  [DOI]
12.  Liao WC, Tu YK, Wu MS, Wang HP, Lin JT, Leung JW, Chien KL. Balloon dilation with adequate duration is safer than sphincterotomy for extracting bile duct stones: a systematic review and meta-analyses. Clin Gastroenterol Hepatol. 2012;10:1101-1109.  [PubMed]  [DOI]
13.  Bergman JJ, van Berkel AM, Bruno MJ, Fockens P, Rauws EA, Tijssen JG, Tytgat GN, Huibregtse K. A randomized trial of endoscopic balloon dilation and endoscopic sphincterotomy for removal of bile duct stones in patients with a prior Billroth II gastrectomy. Gastrointestinal endoscopy. 2001;53:19-26.  [PubMed]  [DOI]
14.  Park TY, Kang JS, Song TJ, Lee SS, Lee H, Choi JS, Kim HJ, Jang JW. Outcomes of ERCP in Billroth II gastrectomy patients. Gastrointest Endosc. 2015; Epub ahead of print.  [PubMed]  [DOI]
15.  Ito K, Masu K, Kanno Y, Ohira T, Noda Y. Ampullary intervention for bile duct stones in patients with surgically altered anatomy. Dig Endosc. 2014;26 Suppl 2:116-121.  [PubMed]  [DOI]
16.  Sato H, Kodama T, Takaaki J, Tatsumi Y, Maeda T, Fujita S, Fukui Y, Ogasawara H, Mitsufuji S. Endoscopic papillary balloon dilatation may preserve sphincter of Oddi function after common bile duct stone management: evaluation from the viewpoint of endoscopic manometry. Gut. 1997;41:541-544.  [PubMed]  [DOI]
17.  Kurumado K, Nagai T, Kondo Y, Abe H. Long-term observations on morphological changes of choledochal epithelium after choledochoenterostomy in rats. Dig Dis Sci. 1994;39:809-820.  [PubMed]  [DOI]
18.  Kurumado K, Abe H. Ultrastructural study on hyperplastic epithelium of rat common bile duct after choledochoenterostomy. Dig Dis Sci. 1995;40:2561-2567.  [PubMed]  [DOI]
19.  Mac Mathuna P, Siegenberg D, Gibbons D, Gorin D, O’Brien M, Afdhal NA, Chuttani R. The acute and long-term effect of balloon sphincteroplasty on papillary structure in pigs. Gastrointest Endosc. 1996;44:650-655.  [PubMed]  [DOI]
20.  Kawabe T, Komatsu Y, Isayama H, Takemura T, Toda N, Tada M, Imai Y, Shiratori Y, Omata M. Histological analysis of the papilla after endoscopic papillary balloon dilation. Hepatogastroenterology. 2003;50:919-923.  [PubMed]  [DOI]
21.  Isayama H, Komatsu Y, Inoue Y, Toda N, Shiratori Y, Tsujino T, Yamada H, Saitou K, Kawabe T, Omata M. Preserved function of the Oddi sphincter after endoscopic papillary balloon dilation. Hepatogastroenterology. 2003;50:1787-1791.  [PubMed]  [DOI]
22.  Yasuda I, Tomita E, Enya M, Kato T, Moriwaki H. Can endoscopic papillary balloon dilation really preserve sphincter of Oddi function? Gut. 2001;49:686-691.  [PubMed]  [DOI]
23.  Kondo S, Yamamoto N, Nakai Y, Sasahira N, Hirano K, Tsujino T, Isayama H, Toda N, Komatsu Y, Tada M. Preservation of papillary relaxation after endoscopic papillary balloon dilation. Hepatogastroenterology. 2008;55:855-858.  [PubMed]  [DOI]
24.  Lu Y, Wu JC, Liu L, Bie LK, Gong B. Short-term and long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Eur J Gastroenterol Hepatol. 2014;26:1367-1373.  [PubMed]  [DOI]
25.  Seo YR, Moon JH, Choi HJ, Kim DC, Ha JS, Lee TH, Cha SW, Cho YD, Park SH, Kim SJ. Comparison of endoscopic papillary balloon dilation and sphincterotomy in young patients with CBD stones and gallstones. Dig Dis Sci. 2014;59:1042-1047.  [PubMed]  [DOI]
26.  Doi S, Yasuda I, Mukai T, Iwashita T, Uemura S, Yamauchi T, Nakashima M, Adachi S, Shimizu M, Tomita E. Comparison of long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation: a propensity score-based cohort analysis. J Gastroenterol. 2013;48:1090-1096.  [PubMed]  [DOI]
27.  Kojima Y, Nakagawa H, Miyata A, Hirai T, Ohyama I, Okada A, Hiramatsu T, Ohhara Y, Kuwahara T. Long-term prognosis of bile duct stones: endoscopic papillary balloon dilatation versus endoscopic sphincterotomy. Dig Endosc. 2010;22:21-24.  [PubMed]  [DOI]
28.  Peng YC, Lin CL, Hsu WY, Chow WK, Lee SW, Yeh HZ, Chang CS, Kao CH. Association of Endoscopic Sphincterotomy or Papillary Balloon Dilatation and Biliary Cancer: A Population-Based Cohort Study. Medicine (Baltimore). 2015;94:e926.  [PubMed]  [DOI]
29.  Itoi T, Tsuyuguchi T, Takada T, Strasberg SM, Pitt HA, Kim MH, Belli G, Mayumi T, Yoshida M, Miura F. TG13 indications and techniques for biliary drainage in acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013;20:71-80.  [PubMed]  [DOI]
30.  Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M. Guidelines on the management of common bile duct stones (CBDS). Gut. 2008;57:1004-1021.  [PubMed]  [DOI]
31.  Dumonceau JM, Andriulli A, Deviere J, Mariani A, Rigaux J, Baron TH, Testoni PA. European Society of Gastrointestinal Endoscopy (ESGE) Guideline: prophylaxis of post-ERCP pancreatitis. Endoscopy. 2010;42:503-515.  [PubMed]  [DOI]
32.  Maple JT, Ikenberry SO, Anderson MA, Appalaneni V, Decker GA, Early D, Evans JA, Fanelli RD, Fisher D, Fisher L. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc. 2011;74:731-744.  [PubMed]  [DOI]
33.  Fujita N, Maguchi H, Komatsu Y, Yasuda I, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc. 2003;57:151-155.  [PubMed]  [DOI]
34.  Watanabe H, Yoneda M, Tominaga K, Monma T, Kanke K, Shimada T, Terano A, Hiraishi H. Comparison between endoscopic papillary balloon dilatation and endoscopic sphincterotomy for the treatment of common bile duct stones. J Gastroenterol. 2007;42:56-62.  [PubMed]  [DOI]
35.  Minami A, Nakatsu T, Uchida N, Hirabayashi S, Fukuma H, Morshed SA, Nishioka M. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci. 1995;40:2550-2554.  [PubMed]  [DOI]
36.  Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, Tytgat GN, Huibregtse K. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bileduct stones. Lancet. 1997;349:1124-1129.  [PubMed]  [DOI]
37.  Ochi Y, Mukawa K, Kiyosawa K, Akamatsu T. Comparing the treatment outcomes of endoscopic papillary dilation and endoscopic sphincterotomy for removal of bile duct stones. J Gastroenterol Hepatol. 1999;14:90-96.  [PubMed]  [DOI]
38.  Arnold JC, Benz C, Martin WR, Adamek HE, Riemann JF. Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: a prospective randomized pilot study. Endoscopy. 2001;33:563-567.  [PubMed]  [DOI]
39.  Natsui M, Narisawa R, Motoyama H, Hayashi S, Seki K, Wakabayashi H, Itoh S, Asakura H. What is an appropriate indication for endoscopic papillary balloon dilation? Eur J Gastroenterol Hepatol. 2002;14:635-640.  [PubMed]  [DOI]
40.  Vlavianos P, Chopra K, Mandalia S, Anderson M, Thompson J, Westaby D. Endoscopic balloon dilatation versus endoscopic sphincterotomy for the removal of bile duct stones: a prospective randomised trial. Gut. 2003;52:1165-1169.  [PubMed]  [DOI]
41.  Tanaka S, Sawayama T, Yoshioka T. Endoscopic papillary balloon dilation and endoscopic sphincterotomy for bile duct stones: long-term outcomes in a prospective randomized controlled trial. Gastrointest Endosc. 2004;59:614-618.  [PubMed]  [DOI]
42.  Minakari M, Samani RR, Shavakhi A, Jafari A, Alijanian N, Hajalikhani M. Endoscopic papillary balloon dilatation in comparison with endoscopic sphincterotomy for the treatment of large common bile duct stone. Adv Biomed Res. 2013;2:46.  [PubMed]  [DOI]
43.  Kim KH, Kim TN. Endoscopic papillary large balloon dilation in patients with periampullary diverticula. World J Gastroenterol. 2013;19:7168-7176.  [PubMed]  [DOI]
44.  Hwang JC, Kim JH, Lim SG, Kim SS, Shin SJ, Lee KM, Yoo BM. Endoscopic large-balloon dilation alone versus endoscopic sphincterotomy plus large-balloon dilation for the treatment of large bile duct stones. BMC Gastroenterol. 2013;13:15.  [PubMed]  [DOI]
45.  Li QL, Gao WD, Zhang C, Zhou PH, Zhong YS, Chen WF, Zhang YQ, Yao LQ, Xu MD. Is endoscopic sphincterotomy plus large-balloon dilation a better option than endoscopic large-balloon dilation alone in removal of large bile duct stones? A retrospective comparison study. Indian J Cancer. 2015;51 Suppl 2:e13-e17.  [PubMed]  [DOI]
46.  Oh MJ, Kim TN. Prospective comparative study of endoscopic papillary large balloon dilation and endoscopic sphincterotomy for removal of large bile duct stones in patients above 45 years of age. Scand J Gastroenterol. 2012;47:1071-1077.  [PubMed]  [DOI]
47.  Omuta S, Maetani I, Saito M, Shigoka H, Gon K, Tokuhisa J, Naruki M. Is endoscopic papillary large balloon dilatation without endoscopic sphincterotomy effective? World J Gastroenterol. 2015;21:7289-7296.  [PubMed]  [DOI]
48.  Kogure H, Tsujino T, Isayama H, Takahara N, Uchino R, Hamada T, Miyabayashi K, Mizuno S, Mohri D, Yashima Y. Short- and long-term outcomes of endoscopic papillary large balloon dilation with or without sphincterotomy for removal of large bile duct stones. Scand J Gastroenterol. 2014;49:121-128.  [PubMed]  [DOI]
49.  Jeong S, Ki SH, Lee DH, Lee JI, Lee JW, Kwon KS, Kim HG, Shin YW, Kim YS. Endoscopic large-balloon sphincteroplasty without preceding sphincterotomy for the removal of large bile duct stones: a preliminary study. Gastrointest Endosc. 2009;70:915-922.  [PubMed]  [DOI]
50.  Chan HH, Lai KH, Lin CK, Tsai WL, Wang EM, Hsu PI, Chen WC, Yu HC, Wang HM, Tsay FW. Endoscopic papillary large balloon dilation alone without sphincterotomy for the treatment of large common bile duct stones. BMC Gastroenterol. 2011;11:69.  [PubMed]  [DOI]
51.  Lin CK, Lai KH, Chan HH, Tsai WL, Wang EM, Wei MC, Fu MT, Lo CC, Hsu PI, Lo GH. Endoscopic balloon dilatation is a safe method in the management of common bile duct stones. Dig Liver Dis. 2004;36:68-72.  [PubMed]  [DOI]
52.  Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014;46:799-815.  [PubMed]  [DOI]
53.  Akiyama D, Hamada T, Isayama H, Nakai Y, Tsujino T, Umefune G, Takahara N, Mohri D, Kogure H, Matsubara S. Superiority of 10-mm-wide balloon over 8-mm-wide balloon in papillary dilation for bile duct stones: A matched cohort study. Saudi J Gastroenterol. 2015;21:213-219.  [PubMed]  [DOI]
54.  Li NP, Liu JQ, Zhou ZQ, Ji TY, Cai XY, Zhu QY. Ampulla dilation with different sized balloons to remove common bile duct stones. World J Gastroenterol. 2013;19:903-908.  [PubMed]  [DOI]
55.  Liao WC, Lee CT, Chang CY, Leung JW, Chen JH, Tsai MC, Lin JT, Wu MS, Wang HP. Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc. 2010;72:1154-1162.  [PubMed]  [DOI]
56.  Bang BW, Lee TH, Song TJ, Han JH, Choi HJ, Moon JH, Kwon CI, Jeong S. Twenty-Second versus Sixty-Second Dilation Duration in Endoscopic Papillary Balloon Dilation for the Treatment of Small Common Bile Duct Stones: A Prospective Randomized Controlled Multicenter Trial. Clin Endosc. 2015;48:59-65.  [PubMed]  [DOI]
57.  Kuo CM, Chiu YC, Changchien CS, Tai WC, Chuah SK, Hu TH, Kuo YH, Kuo CH. Endoscopic papillary balloon dilation for removal of bile duct stones: evaluation of outcomes and complications in 298 patients. J Clin Gastroenterol. 2012;46:860-864.  [PubMed]  [DOI]
58.  Tsujino T, Kawabe T, Isayama H, Sasaki T, Kogure H, Togawa O, Arizumi T, Ito Y, Matsubara S, Yamamoto N. Efficacy and safety of low-pressured and short-time dilation in endoscopic papillary balloon dilation for bile duct stone removal. J Gastroenterol Hepatol. 2008;23:867-871.  [PubMed]  [DOI]
59.  Seo YR, Moon JH, Choi HJ, Kim DC, Lee TH, Cha SW, Cho YD, Park SH, Kim SJ. Papillary balloon dilation is not itself a cause of post-endoscopic retrograde cholangiopancreatography pancreatitis; results of anterograde and retrograde papillary balloon dilation. J Gastroenterol Hepatol. 2013;28:1416-1421.  [PubMed]  [DOI]
60.  Tsujino T, Isayama H, Komatsu Y, Ito Y, Tada M, Minagawa N, Nakata R, Kawabe T, Omata M. Risk factors for pancreatitis in patients with common bile duct stones managed by endoscopic papillary balloon dilation. Am J Gastroenterol. 2005;100:38-42.  [PubMed]  [DOI]
61.  Fujisawa T, Kagawa K, Ochiai K, Hisatomi K, Kubota K, Sato H, Nakajima A, Matsuhashi N. Prophylactic Efficacy of 3- or 5-cm Pancreatic Stents for Preventing Post-ERCP Pancreatitis: A Prospective, Randomized Trial. J Clin Gastroenterol. 2016;50:e30-e34.  [PubMed]  [DOI]
62.  Fujisawa T, Kagawa K, Watanabe S, Hisatomi K, Kubota K, Sato H, Nakajima A, Matsuhashi N. Endoscopic nasobiliary drainage for obstructive jaundice using either a 5 Fr or 7 Fr catheter: a prospective, randomized trial. BMC Gastroenterol. 2014;14:161.  [PubMed]  [DOI]
63.  Sato D, Shibahara T, Miyazaki K, Matsui H, Yanaka A, Nakahara A, Tanaka N. Efficacy of endoscopic nasobiliary drainage for the prevention of pancreatitis after papillary balloon dilatation: a pilot study. Pancreas. 2005;31:93-97.  [PubMed]  [DOI]
64.  Xu XD, Dai JJ, Qian JQ, Wang WJ. Prevention of pancreatitis after papillary balloon dilatation by nasobiliary drainage: a randomized controlled trial. Dig Dis Sci. 2015;60:1087-1091.  [PubMed]  [DOI]
65.  Xu XD, Dai JJ, Qian JQ, Wang WJ. Nasobiliary drainage after endoscopic papillary balloon dilatation may prevent postoperative pancreatitis. World J Gastroenterol. 2015;21:2443-2449.  [PubMed]  [DOI]
66.  Sherman S, Ruffolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy. A prospective series with emphasis on the increased risk associated with sphincter of Oddi dysfunction and nondilated bile ducts. Gastroenterology. 1991;101:1068-1075.  [PubMed]  [DOI]
67.  Smithline A, Silverman W, Rogers D, Nisi R, Wiersema M, Jamidar P, Hawes R, Lehman G. Effect of prophylactic main pancreatic duct stenting on the incidence of biliary endoscopic sphincterotomy-induced pancreatitis in high-risk patients. Gastrointest Endosc. 1993;39:652-657.  [PubMed]  [DOI]